21585. Misbranding of  Premo  Ergot-Apiol  Capsules.    TJ.   S.  v.   39  Tins   of
Premo   Ergot-Apiol   Capsules.    Default   decree   of   condemnation, 
forfeiture, and destruction.     (F. & D. no. 30873.     Sample no. 42977-A.)
Examination of the drug product involved in this case disclosed that it con- 
tained no ingredient or combination of ingredients capable of producing certain 
curative or therapeutic effects claimed in the labeling.
On August 9, 1933, the United States attorney for the .Middle District of 
Pennsylvania, acting upon a report by the Secretary of Agriculture, filed in 
the district court a libel praying seizure and condemnation of 39 tins of Premo 
Ergot-Apiol capsules at Wilkes-Barre, Pa., alleging that the article had been 
shipped in interstate commerce on or about July 15, 1933, by Blackman & 
Blackman, from New York, N.Y., and charging misbranding in violation of the 
Food and Drugs Act as amended.
Analysis of a sample of the article by this Department showed that it 
consisted essentially of material derived from plants, including aloin, a non- 
volatile oil such as apiol, a volatile oil such as savin oil, and traces of ergot 
alkaloids.
It was alleged in the libel that the article was misbranded in that the 
following statements regarding the curative and therapeutic effects were false 
and fraudulent: (Tin container) "For Dysmenorrhea, Amenorrhea and 
Menstrual Disorders", (circular) "For Dysmenorrhea, Amenorrhea and 
Menstrual Disorders * * * For the Treatment of Menstrual Disorders. 
It relieves pain * * * for use in the treatment of menstrual dis- 
orders. * * * Ergot-Apiol ' Prema is valuable and is generally indicated 
in the conditions described below. * * * Amenorrhea—When menstrual 
flow is scanty or absent as a result of exposure, shock or nervous strain, one 
capsule should be taken three times a day for three days, then increased to 
two capsules three times daily until flow has been established. Then it is 
reduced to one capsule twice a day. Dysmenorrhea—Where the complaint is 
chronic ' Prema Ergot-Apiol should be taken a few days in advance of the 
period and continued until the flow has ceased. In most cases one capsule four 
times a day is sufficient, but when pain is unusually severe two capsules may 
be given four times a day. Menorrhagia—When the flow is excessive, resulting 
in weakness and lack of energy, one capsule may be administered four times 
a day. Menostasis—To re-establish the flow two capsules may be administered 
three or four times a day, in conjunction with frequent sitz baths if pre- 
ferred. Menopause—Ergot-Apiol prema will be found an aid in easing the 
disturbances attending final cessation of the menstrual functions. One capsule 
two or three times a day is advised."
On October 10, 1933, no claimant having appeared for the property, judgment 
of condemnation and forfeiture was entered, and it was ordered by the court 
that the product be destroyed by the United States marshal.
M. L. WILSON, Acting Secretary of Agriculture.